Wednesday, February 11, 2009

Hubbard testimony - Feb. 5 - Alliance for a stronger FDA

Excerpts from the testimony of William Hubbard before the Senate Agriculture Commitee on Feb. 5:

William K. Hubbard
Alliance for a Stronger FDA
Before the
Committee on Agriculture, Nutrition and Forestry
United States Senate
Washington, DC

Despite the considerable gloom we have been seeing in recent years related to the failures of our food safety system, there is great reason to be optimistic that we can successfully fix its many flaws. The key will be to move from the current reactive, fragmented system to one that is focused on prevention. FDA and the industry have already demonstrated the possibilities, through development of procedures for preventive controls for low-acid canned foods, seafood, and juice. Known generally as Hazard Analysis Critical Control Points, or HACCP, it is a methodology under which producers undertake four steps to assure the safety of their food, and whose complexity is based on the risks posed to the food:
1) Analyze hazards, that is, understand what hazards their food might be subjected to so
that they can eliminate them,
2) Develop a food safety plan under which they will take the necessary steps to control the dentified hazards,
3) Document the steps the facility takes to implement the plan, thereby creating a record of how they successfully control the hazards, and can thus assure both regulators and their customers that they are always vigilant about food safety, and
4) Meet standards for minimizing risk in their food, such as by periodic testing for hazards to assure that the finished product is indeed uncontaminated.

These are often fairly simple, common sense steps, but they have shown a remarkable capacity to effectively prevent food contamination. In the case of a peanut butter processor, for example, the four steps might be implemented as follows:
1) Hazard identification would likely be focused on bacterial contamination,
2) The food safety plan would identify the need to a) roast the raw peanuts at sufficiently high temperature to ensure that any bacteria arriving from the farm is killed, then, b) keep the processing equipment clean so that the peanut butter is not exposed to bacteria while being processed and packaged. This would also include the need to guard against rodent and insect infestation, leaky roofs, and any other threat to equipment sanitation.
3) Documentation might include only temperature recording of the roaster while it is in operation and the recording of regular, thorough cleaning of the processing equipment; and, finally,
4) Performance Standards could be met by periodic sampling and testing of the final product, to confirm that it is free of bacteria. Under such a new paradigm, FDA’s role would shift from its current “gotcha” mode via random inspections to one in which they set the requirements for preventive controls and any necessary quantitative tolerances for contaminants, train and educate processors in the use of such controls, assess the adequacy of firms’ food safety plans, and oversee an inspection regime under which FDA, state, local, and other third-party inspectors can confirm the proper implementation of food safety plans.


FDA cannot move to the type of modern food safety system that is needed without statutory change. Specifically, I believe the Congress should enact legislation with the following elements:
First, empower FDA to mandate preventive controls for all food. Many, if not most, large processors have already adopted some form of preventive controls, but such a system will only be as strong as its weakest link, and FDA must be specifically charged with requiring universal HACCP-like processes. Second, give FDA the resources to be successful in a new food safety system. In the 1970s, when FDA’s food program was at its zenith, its budget was one-half of the agency’s budget, and that could be a goal for restoring the program to health. It would require additional funding of about $500 million, or about 2 cents a week for eachAmerican. Without the resources to strengthen the FDA, no authorities can or will bring the change that is needed, but I believe the vast majority of Americans would gladly paya penny every few days for a safer food supply. Indeed, the cost to the taxpayer would likely be recouped by savings to consumers through the elimination of just one major outbreak a year. Third, enact long overdue enforcement authorities for FDA, such as mandatory recall authority, annual registration for all food facilities, a revised administrative detention authority, accreditation of private laboratories, and a stronger traceback authority. Fourth, direct the Secretary of Health and Human Services to develop an effective crisis management system that coordinates the response to foodborne disease outbreaks among CDC, FDA, and state and local government; cuts through the current bickering and turf battles among those entities; and effectively shortens the response time and resolution of future outbreak. And, fifth, authorize and fund a food safety training academy that will provide uniform, science-based training for all food inspectors, at all levels of government and in the private sector.

In conclusion, Mr. Chairman, today’s hearing is another in a series that Congress has held to highlight instances where FDA needs to improve, and I agree with your concerns that FDA is not as effective as it can and should be. In the case of food, we have a real dichotomy between our rhetoric and our action. As I noted earlier, we say we want a strong FDA and a strong food safety system, but our actions belie that stated objective. We have not given FDA the authority and resources it needs to be the agency we want it to be, and then we are critical of it when it fails to meet expectations. Meanwhile, as report after report recommends dramatic change in our food safety oversight, the number of foodborne disease outbreaks have risen from about 100 per year fifteen years ago to 350 per year more recently. That is a record for which we should be truly embarrassed, and I sincerely hope that you and your colleagues will agree with my conclusions and resolve to act upon them.

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